CYB003 Development

CYB003 has the potential to effectively treat major depressive disorder (MDD) and alcohol use disorder (AUD). CYB003 is a deuterated psilocybin analog designed to achieve less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability versus oral psilocybin, for an overall better outcome for patients.

Completion of IND-enabling development:

Cybin plans to submit a preclinical package to support clinical development (efficacy and safety) of CYB003 according to regulatory guidelines.

An optimized pharmacokinetic (PK) profile will be used to predict efficacious and safe human doses.

Cybin has completed its IND-enabling preclinical studies of CYB003 and plans to submit an IND to the FDA in Q2 2022 with an expected Phase 1/2a trial initiation in mid-2022.

To achieve better outcomes for patients, Cybin’s focus is on an improved therapeutic deuterated psilocybin analog with:

Less Variability in plasma levels
Faster onset of
action
Shorter duration of effect
Potentially better tolerability

Deuterated Psilocybin Analog

CYB003 has the potential to effectively treat major depressive disorder (MDD) and alcohol use disorder (AUD) with potential for reduced side effects associated with other psychedelic-based therapies currently in development.

 

CYB003 Provides Therapeutic Advantages over Oral Psilocybin

Properties Psilocybin CYB003 Potential benefits for patients
Psychedelic properties Therapeutic effects
Low variability in plasma levels X Safer dosing and more predictable patient outcomes
Fast onset of action X Less down time in clinic and faster onset of effects
Short total duration of action X Shorter clinic days and costs
Rapid brain distribution X Therapeutic effects at lower doses, potentially better tolerability

CYB003 Demonstrates Promising Preclinical Results

CYB003 could potentially reduce clinic time for patients by 50%

Psilocybin
CYB003

Time (Hours)

0          0.2          0.4          0.6          0.8           1

CYB003 onset of action is 2X as fast as oral
psilocybin
Psilocybin
CYB003

Time (Hours)

0                 1                 2                 3                  4

CYB003 duration effects are cut in half compared to oral psilocybin

Upon ingestion, psilocybin is rapidly converted to psilocin, which acts as a partial agonist for 5-HT2A receptors with effects lasting 4-6 hours. Psilocybin analogs such as CYB003, are specifically engineered to bind 5-HT receptors with better affinity. As a result, CYB003’s onset of action is faster, and the duration of effect is shorter acting, therefore improving convenience for clinical setting administration. 

CYB003 Could Have Potentially Reduced Side Effects

Psilocybin
CYB003

Brain to Plasma Ratio of Active Agent

0          2          4          6          8          10          12

Improved brain to plasma ratio could result in therapeutic effects at lower doses and less side-effects

People metabolize psilocybin at different speeds, making it difficult to find one dose that works for all patient groups. Therefore, there is strong demand for molecules with similar therapeutic properties but more controlled pharmacokinetic profiles. Encouraging preclinical data demonstrated CYB003 plasma concentration profiles were less variable than psilocybin and had improved brain penetration ratios. The data suggests CYB003 could result in therapeutic effects with safer dosing options and more predictable patient outcomes.